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Manufacturing Specialist III
Ref No.: 17-00686
Location: Allston, Massachusetts
Start Date / End Date: 02/13/2017 to 08/18/2017
The Facilities Specialist uses expert knowledge of compliance and CGMP manufacturing processes to manage and own all process related documents, to include investigations and improvement initiatives within area of responsibility.
Responsibilities include:
The Facilities Specialist uses process knowledge to manage and own all Preventative Maintenance (PM) related process documents, to include: investigations, training, and improvement initiatives within a defined area.
Assists with the Document Change Request (DCR) for all process related SOPs and Preventative Maintenance (PM) Records ensuring accuracy and consistency. The Facilities Specialist authors complex, explicit documentation for new and current procedures.
Assists in the process of deviation management and root cause analysis for applicable deviations. The Facilities Specialist creates and presents trending and metrics reports on deviations and corrective actions.
Develops Facilities training curricula and works with Supervisors and the Quality Training group to develop and ensure consistency in training materials through the on-the-job training program on process operations, theory, and compliance. Occasionally performs training with staff on the floor as well as train-the-trainer activities.
Effectively demonstrates an understanding of CGMPs & how it applies to specific responsibilities.
Practices safe work habits and adheres to Genzyme’s safety procedures and guidelines.
Trains new employees.
Routinely interacts with support groups. Understands and maintains production schedule. May recommend development opportunities for less experienced co-workers
Collaborates with MFG, QA, QC, MTS, Validation, Scheduling, and Manufacturing Engineering to
implement change in process, procedures, project milestones, and work practices.
As a continuous improvement driver, the Facilities Specialist helps manage the implementation of projects and new business processes and systems.

Bachelor’s Degree
Experience working for a maintenance organization in a CGMP Biotech/Pharmaceutical manufacturing environment
Training, coaching, leadership experience.
Experience with Cycle development, Shakedown, Engineering support, Commissioning and Qualification, and Validation of process equipment
Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents
Experience with TrackWise, LiveLink, Gage Insight (IndySoft) and Microsoft Office
Experience in troubleshooting, investigation, and root cause analysis in a current good manufacturing practices (CGMP) environment.